In
the 1973 science fiction film Soylent Green, directed by Richard Fleisher
and starring Charlton Heston as Thor, the government combined with industry
to euthanize people deemed of low social utility and use their corpses
to make a food source called Soylent Green, which was then fed to a
starving population unaware of its true source. Whenever government
supplants the right of an individual in making penultimate treatment
decisions in the face of terminal illness, the people are robbed of
their right to liberty and to life. The grotesque abuse of government
power portrayed in Soylent Green has a modern corollary in the FDA that
is equally horrific.

Under
FDA regulations a patient who is terminally ill may only gain access
to an investigational drug if the FDA approves. FDA approval is required
even if the attending physician recommends the drug and the sponsor
is willing to provide it. In this way, FDA stands between the terminally
ill and access to potentially life saving drugs. Hundreds of people
have been deprived of all hope and freedom of choice by the barbaric
exercise of life-ending power by the Food and Drug Administration.

In
1999 Abigail Burroughs, a nineteen year old University of Virginia student,
was diagnosed with a rare cancer of the head and neck. For eighteen
months, she underwent painful chemotherapy and radiation treatments,
those approved by FDA, to no avail. In March of 2001, Abigail and her
parents were informed that the FDA approved treatments had failed and
that her only hope lay in gaining access to investigational drugs, Erbitux
and Iressa, then undergoing clinical trials. Abigail’s cancer
cells had very high Epidermal Growth Factor Receptors, and EGFRs had
been shown preliminarily to be greatly suppressed by these two experimental
drugs. The sponsors of the drug trials were willing to provide the experimental
drugs to Abigail, but they had to first obtain the consent of the FDA.
The FDA refused to grant its consent, and Abigail died on June 9, 2001,
at the age of twenty-one.

In
the spring of 2001 sixteen year old high school student David Baxter
was diagnosed with colorectal cancer. Although there was little chance
that FDA approved chemotherapy would be successful, he proceeded through
his chemotherapy rounds. David was denied access to investigational
drugs by FDA on the basis that he was not yet eighteen, and the trials
were said to be only available for those eighteen and older. He died
shortly before his seventeenth birthday on July 20, 2002.

Kianna
Karnes was a forty-four year old mother of four and grandmother of one
when she was diagnosed with kidney cancer that was said to have metastasized.
Two different investigational drugs, BAY 43-9006 and SU 11248, were
promising for what was regarded as an otherwise untreatable disease.
Despite appeals for access to the drugs, FDA refused to grant access
until her condition had advanced to its final stage. FDA refused to
grant Karnes access to one of the experimental drugs but finally changed
its position, issuing notice of a grant of access to Karnes on the day
she died in 2005.

Thirteen
year old Anna Tomalis was diagnosed with embryonal sarcoma. She underwent
FDA approved chemotherapy and surgery but both failed. Her parents then
endeavored to have Anna treated with an investigational drug, Deforolimus,
developed by Merck and ARIAD. FDA refused to grant Tomalis access to
the drug until three weeks before she died, at a stage of cancer progression
beyond that effectively treatable by the investigational drug.

Many,
like Patricia Clarkson (the subject of my article for Newswithviews
entitled FDA Condemnation of the Terminally Ill), are presently diagnosed
with terminal cancer and have been informed that FDA approved treatments
are not likely efficacious, yet their requests for access to investigational
drugs have been denied by the FDA.

On
August 3, 2012, Congressman Ron Paul introduced the Compassionate Freedom
of Choice Act, HR 6342. Under that bill, if a patient has been diagnosed
with a terminal illness and a physician has determined that FDA approved
drugs and devices are unlikely to be curative, the patient may obtain
access to an investigational drug if the sponsor is willing to supply
it and the patient executes an informed consent. The bill removes FDA
from the picture, restoring medical freedom to the patient and the practice
of medicine to attending physicians. The bill also removes a perverse
incentive now present in FDA regulations. FDA requires sponsors of clinical
trials to report the results of treatments to those given compassionate
access. Because adverse findings may have an impact on drug approval,
sponsors are often dissuaded from granting access for fear that it will
redound to their detriment in the drug approval process. Congressman
Paul’s bill eliminates the requirement that any information concerning
compassionate access be supplied to the FDA.

Congressman
Paul’s bill is co-sponsored by Congressmen Charles Broun of Georgia
and Richard L. Hanna of New York. It is pending before the House Energy
and Commerce Committee, chaired by Fred Upton of Michigan. On this bill
depends the lives of many terminally ill patients. Without the bill,
every terminally ill patient who seeks access to an experimental drug
must grovel before the FDA, begging for the right to receive the drug
which is that person’s only hope for survival. No American, and
certainly none fighting to remain alive, should be subjected to that
humiliation, and no person in government, and certainly not an FDA bureaucrat,
should ever stand between the terminally ill and access to a potentially
life-saving drug.

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I
list here each member of the Energy and Commerce Committee. Please examine
the list. If your member of Congress is on it, I urge you to call or
email him or her today. Ask your representative to co-sponsor HR 6342.
If your member of Congress is not on this list, please call or email
the chairman of the committee, Fred Upton of Michigan, and urge him
to co-sponsor this bill. This is not a partisan issue, it is a humanitarian
measure of critical and immediate need.

Jonathan
W. Emord is an attorney who practices constitutional and administrative
law before the federal courts and agencies. Congressman Ron Paul calls
Jonathan “a hero of the health freedom revolution” and says
“all freedom-loving Americans are in [his] debt . . . for his courtroom
[victories] on behalf of health freedom.” He has defeated the FDA
in federal court a remarkable eight times, six on First Amendment
grounds, and is the author of Amazon bestsellers The
Rise of Tyranny, Global
Censorship of Health Information,
and Restore
the Republic. He is also the American Justice columnist for
U.S.A. Today Magazine. For more info visit Emord.com.

Under
FDA regulations a patient who is terminally ill may only gain access to
an investigational drug if the FDA approves. FDA approval is required
even if the attending physician recommends the drug and the sponsor is
willing to provide it....